In a stunning federal court order JAMES M. ROSENBAUM, US Chief District Judge in Minnesota, overturned FDA-supported pre-emption arguments in their entirety!

“The FDA has no authority to declare, ipse dixit, that a label is false and misleading.” p.8 [“ipse dixit” = unproven assertion]

The case of Kimberly Kay Witczak v. Pfizer (04-CV-2819(JMR/FLN), hinges on Pfizer’s failure to warn about the suicide risk on the label of its antidepressant, Zoloft.

The court ruling rejects Big Pharma’s pre-emption defense in cases involving wrongful deaths due to manufacturers’ failure to warn about lethal drug side-effects, such as suicide linked to their drugs. The Court called Pfizer’s arguments a “public policy argument gone awry.” (p. 10)

The Court called the pre-emption argument made by Daniel Troy, when he was FDA’s chief counsel, “perverse.” “The Court … declines to treat statements from a single FDA legal brief as declarations afforded the preemptive force of law.” (P. 8.)

This Court Order shreds to smithereens each and every argument in support of withholding drug safety information. The judge’s reasoned decisions about the pre-emption argument takes note of the fact that: “FDA regulations are generally minimum standards of conduct” (p. 12) unless Congress has expressed clear intent to preempt state common law, which it has not done here.

(“[T]he [Food Drug and Cosmetics] Act as a whole was designed primarily to protect consumers from dangerous products.”). Any contrary interpretation of Congress’s intent is perverse.”

“The FDA itself vindicated Congress’s protective intent when it issued its March 22, 2004, Public Health Advisory, recommending that SSRI labels be modified to reflect potential suicide risks. the FDA has since distanced itself from the substance of the Motus brief by recommending labeling changes that, in fact, reflect concerns about the association between SSRIs and suicidality. Thus, the Court has “reason to suspect that the [Motus brief’s] interpretation does not reflect the agency’s fair and considered judgment on the matter in question.” (p. 8)

“State consumer-protection law compliments, rather than frustrates, the FDA’s protective regime. This new drug-marketing environment calls out for enhanced consumer protection.”

“The FDA has no authority to declare, ipse dixit, that a label is false and misleading. Rather, the government must initiate an enforcement action to establish that the drug is in fact misbrandedŠ. For all of these reasons, the statements in the Motus brief are insufficient to preempt plaintiff’s failure-to-warn claim.” (p. 8)

The Court took full cognizance of FDA’s new warning requirements following the ground breaking February 2004 hearing which resulted in the FDA reversing its stance (March 22) when it ordered that all antidepressant labels to include explicit warnings about the increased risk of “suicidality” for children and adults who take an SSRI antidepressant.

And the Court notes the effect of direct to consumer drug advertising: “This new drug-marketing environment calls out for enhanced consumer protection.” (P. 12.) “State consumer-protection law compliments, rather than frustrates, the FDA’s protective regime. This is especially apparent when one considers that prescription drugs were once marketed primarily to trained health care providers — sophisticated and discerning intermediaries. Today, on the other hand, pill-rolling apothecaries and the mortar and pestle have disappeared. They have been replaced by drug manufacturers who urge the use of their drugs in mass-market print and television advertisements targeted directly at the public. Defendant, for example, advertises the drug involved in this case by personifying it as a happy, bouncing-oval cartoon character.” (p. 12)

Last week, a California judge struck the FDA’s amicus brief from the court record, stating that it was hearsay and irrelevant, and denied Pfizer’s preemption motion.

The Court in the case, Szybinski v. Pfizer, ruled that “there is nothing to prevent Pfizer from strengthening its warning label,” that “the FDA provides only minimum standards,” and “Pfizer has not shown that plaintiff’s claims would be an obstacle to the accomplishment and excecution of the full purposes and objectives of Congress.”

This is a stunning ruling which also effectively puts to shame the American Medical Association and the American Psychiatric Association for their self-serving positions. [See: http://www.ahrp.org/infomail/05/06/29.php ]